Pediatric Cardiac Output Monitoring Observational Study (POGO)

Edwards Lifesciences

Status: Completed

Conditions: Pediatric ALL

Treatments: Device: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight

Study type: Observational

Funder types: Industry

Identifiers

NCT04465370

2019-08 (Other Identifier)

Details and patient eligibility

About

To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.

Enrollment: 89 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are 12 to 18 years of age
• Subjects who have signed the Informed Consent Form
• Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures
• For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation
• Subjects with planned pressure monitoring with an arterial line

Exclusion criteria

• Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy);
• Subjects with contraindications for Arterial Line Placement;
• Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease).
• Subjects with a physical site area too limited for proper Sensor placement
• Subjects with finger size less than the smallest finger cuff size
• Documented ≥ moderate pulmonary hypertension (PAPm > 25mmHg, PVRI > 3.0 WUxm2)
• Presence of intracardiac shunting (i.e., ASD, VSD)
• Aorto-pulmonary collaterals
• ≥ Moderate tricuspid regurgitation, per echocardiogram criteria
• > Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria
• Persistent cardiac arrythmias during the cardiac catheterization period (> 3min)
• Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)

Trial design